NCT06190054

Evaluation of Performance and Safety of Eye Drops With Hydroxypropyl-methylcellulose and Inositol in Drye Eye Disease

Evaluation of the Efficacy and Safety of an Eye Drops With Hydroxypropyl-methylcellulose and Inositol as Principal Components (MERAMIRT®) in the Treatment of Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a profit, multicentric, prospective, single-arm, open-label, non-pharmacological clinical investigation. Patients with diagnosis of moderate to severe dry eye disease with asthenopia and accommodative effort will receive MERAMIRT®, 1-2 drop per eye 3 times a day for 90 days.

Detailed description

MERAMIRT®, a class IIa medical device, is indicated for hydration and lubrication of the ocular surface under conditions of eye disorders caused by environmental, visual and mechanical stress, also due to asthenopia and accommodation effort. The main component of MERAMIRT® are Hydroxypropyl-methylcellulose (HPMC 0.3%) and Inositol (0.1%). HPMC has the property of moisturizing and lubricating the eye. Inositol is used with an antioxidant role. Hypromellose is a polymer that has the property to tick and stabilize the tear film on the corneal surface, which create a protective, transparent and viscoelastic layer. Inositol, as other osmolytes, may contribute to counteract the oxidant action on free radicals produced in condition of asthenopia and accommodative effort. Such activity may indirectly support the muscular metabolic processes favoring the contractile response. MERAMIRT® is a hydrating and lubricant tear replacement indicated in ocular isturbances caused by environmental, visual and mechanic stress, also due to asthenopia and accommodative effort. In a small, open-label study, a 0.3% hypromellose eye gel showed statistically significant effects in relieving ocular symptoms and in improving ocular comfort in patients with dry eye syndrome. Another recent study showed that treatment with punctual occlusion using hypromellose 2% was associated with a significant reduction in signs and symptoms in patients with dry eye. Based on the preliminary available background on the use of hypromellose in the management of dry eye syndrome, this investigation has been designed to assess the efficacy and safety of a sterile ophthalmic solution that contains hypromellose and inositol (MERAMIRT®), in a sample of VDT users suffering of moderate or severe DED with asthenopia and accommodative effort.

Conditions

• Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users

Interventions

Type	Name	Description
DEVICE	MERAMIRT	MERAMIRT®, a class IIa medical device, is indicated for hydration and lubrication of the ocular surface under conditions of eye disorders caused by environmental, visual and mechanical stress, also due to asthenopia and accommodation effort. The main component of MERAMIRT® are Hydroxypropyl-methylcellulose (HPMC 0.3%) and Inositol (0.1%). HPMC has the property of moisturizing and lubricating the eye. Inositol is used with an antioxidant role

Timeline

• Start date: 2023-02-06
• Primary completion: 2024-07-01
• Completion: 2024-12-01
• First posted: 2024-01-05
• Last updated: 2024-06-12

Locations

4 sites across 1 country: Italy